Good news flowed in at
) with Health Canada approving Opsumit 10 mg once daily for
the long-term treatment of pulmonary arterial hypertension (PAH
WHO Group I). Opsumit will be used to reduce morbidity in
patients of WHO Functional Class II or III whose PAH is either
idiopathic or heritable, or associated with connective tissue
disease or congenital heart disease.
Results from the SERAPHIN study (n=742) conducted on Opsumit
showed that the risk of a morbidity/mortality event was cut by
45% in patients who were administered Opsumit compared to those
on placebo. The study also showed a reduction in the risk of PAH
related hospitalization and death by 50% as compared to
Actelion will launch Opsumit in Canada in early 2014. Opsumit
is also being evaluated in a pivotal phase III program in
patients suffering from digital ulcers associated with systemic
sclerosis. Results from this study are expected in the first half
of 2014. In addition, Opsumit is being evaluated for the
treatment of glioblastoma (phase I).
In the last month, the U.S. Food and Drug Administration
approved Opsumit 10 mg once daily for the treatment of PAH
WHO Group I to delay disease progression. It will be launched in
the U.S. shortly. Actelion also received a positive opinion from
the Committee for Medicinal Products for Human Use of the
European Medicines Agency for Opsumit. Opsumit is currently under
review in other countries like Switzerland, Australia, Taiwan,
Korea and Mexico.
We note that an interesting PAH candidate in Actelion's
pipeline is selexipag. The candidate is in phase III studies with
final results due in mid-2014.
Actelion carries a Zacks Rank #1 (Strong Buy). Currently,
Jazz Pharmaceuticals Ltd.
Impax Laboratories Inc. (
also look attractive. Jazz Pharma and Impax Labs carry a Zacks
Rank #1 while Bayercarriesa Zacks Rank #2 (Buy).
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